During an inspection of your establishment located in Hialeah, Florida on September 9-21, 2005, an FDA investigator determined that your establishment is a manufacturer and distributor of alginate impression material, zinc phosphate cement, and polycarboxylate cement (Class II) and other dental OTC devices (Class 1). These are devices, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h).

The investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820, and the Medical Device Reporting part 803. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] and misbranded within the meaning of Section 502(t)(2) [21 U.S.C. 352(t)(2)] of the Act.

The Act requires that manufacturers conform to the QS Regulation for medical devices, as specified in 21 CFR Part 820 and Medical Device Reporting, as specified in 21 CFR Part 803.

Quality System Regulation

The investigator noted the following deviations from the QS regulation:

1 . Your firm failed to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. Your firm has never conducted a quality audit (FDA 483, Item #1).

2. Your firm's management with executive responsibility failed to establish its policy and objectives for, and commitment to quality. Management shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization as required by 21 CFR 820.20(a-e). Your firm has not ensured that the quality policy has been fully implemented and maintained per 820.20(a), (FDA 483, Item #s 2 & 8); adequate resources have not been provided to perform assessment activities and audits, and personnel have not been adequately trained to perform assessment activities and audits per 820.20(b)(2), (FDA 483, Item #s 5 & 6); you have failed to ensure that quality system requirements are effectively established and maintained per 820 .20(b)(3)(i), (FDA 483, Item #3); you failed to ensure that management shall review the suitability and effectiveness of the quality system at defined intervals pursuant to established procedures to ensure the quality system is effective and that the dates and results of the quality system review shall be documented per 820.20(c), (FDA 483, Item #4); you failed to establish a quality plan per 820.20(d), (FDA 483, Item #7); and you failed to establish the quality system procedures and instructions per 820.20(e), (FDA 483, Item #9).

3. Your firm failed to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). The blending, mixing, and filling operations regarding the production and repackaging of all products have not been validated, e.g., alginate impression material, zinc phosphate cement, eugenol liquid, and acid etching gel (FDA 483, Item #25).

4. Your firm failed to establish and implement complaint handling procedures as required by 21 CFR 820.198(a) and failed to investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). Your complaint procedures are not complete to ensure uniform and timely processing, there is no provision for documenting oral complaints, and there is no provision to determine if a complaint is required to be reported under Medical Device Reporting (FDA 483, Item #40); and complaint investigation records fail to document products sampled, tested or the test procedures used (FDA 483, Item #41).

5. Your firm failed to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100(a). Your firm has never initiated corrective or preventive actions and, recently established CAPA procedures have not been reviewed for suitability and implemented (FDA 483, Item #34).

6. Your firm failed to establish and maintain procedures to control the design of device(s) in order to ensure that specified design requirements are met as required by 21 CFR 820.30(a-j). Your firm failed to establish procedures to control the design process per 820.30(a), (FDA 483, Item #13); your firm failed to establish a design and development plan per 820.30(b), (FDA 483, Item #12); your firm failed to document design input requirements per 820.30(c), (FDA 483, Item #15); your firm failed to identify design outputs that are essential for the proper functioning of the device per 820.30(d), (FDA 483, Item #16); your firm failed to establish and maintain procedures to validate the device design including the establishment and documentation of acceptance criteria (FDA 483, Item #17 & 19) and to perform risk analysis (FDA 483, Item #18).

7. Your firm failed to establish and maintain procedures for identifying product during all stages of receipt, production, and distribution as required by 21 CFR 820.60. Products may be labeled as approved but finished product testing is not complete, e.g., zinc phosphate cement liquid, lot 03240502, was labeled as approved but had not completed the filtration process; and zinc phosphate cement liquid in five gallon containers were not identified as to status and were stored in the filtration area. Some had completed the filtration process and were released while others were waiting to be filtered (FDA 483, Item #22).

8. Your firm failed to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements as required by 21 CFR 820.50 and failed to establish and maintain data that clearly describe or reference the specified requirements for acceptance as required by 21 CFR 820.50(b) and 820.80(b). Your firm failed to evaluate raw materials, packaging components, and OEM bulk product (FDA 483, Item #s 20 & 23); and there are no acceptance requirements for raw materials, packaging components and finished products received in bulk (FDA 483, Item #21).

9. Your firm failed to develop, conduct, control, and monitor production processes to ensure that a device(s) conforms to its specifications as required by 21 CFR 820.70(a) & (a)(2). There were no written procedures covering the completion of dental impression material and cement curing tests (FDA 483, Item #27); DHRs show product as accepted when processing steps or testing have not been completed, e.g., zinc phosphate, lot #s 03240502 dated 3/24/05 and 03230501 dated 3/22/05 (FDA 483, Item #30); and Alginate Impression material being packaged on 9/12/05 despite water seepage into the packaging room was not being monitored (FDA 483, Item #28).

10. Your firm failed to establish and maintain procedures for acceptance activities including incoming acceptance and finished product acceptance as required by 21 CFR 820.80. There are no procedures to review accepted raw materials when they are stored for prolonged periods in the warehouse, e.g., IMCIL-A-10 Silica, lot #0355205 released on 9/2/98 and Thixcin-R released on 2/2/98; (FDA 483, Item #23); One ounce Eugenol USP bottles were stored in finished product storage although they have not been labeled/packaged and there was no indication the labeling operation was complete (FDA 483, Item #31); Eugenol USP, lot #06861503 was released for distribution without the signature of a designated individual on or about 9/9/05; and acceptance procedures to ensure specified requirements for in-process product were not established and documented, e.g., the maximum shelf life of bulk stored products before final packaging is not established as documented (FDA 483, Item # 33).

11. Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a) and 70(g)(1). There are no procedures regarding the calibration, inspection, checking, cleaning, and maintenance of the alginate impression material blender (FDA 483, Item #24); and there are no established schedules for cleaning/maintenance of any production equipment and no records are kept of such activities (FDA 483, Item #26).

12. Your firm failed to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities as required by 21 CFR 820.25(a) & (b). No personnel were assigned to ensure that raw materials, packaging materials, labels, in-process intermediates, and finished products meet acceptance specifications or to ascertain when specifications are missing (FDA 483, Item #10); and employees have not been adequately trained, e.g., employees in the alginate impression material manufacturing area continued to package product after becoming aware of rain water that entered this area due to roof damage; and employees responsible for accepting raw materials have not been trained to order and accept suitable ingredients for use in the production of dental devices (FDA 483, Item #11).

13. Your firm failed to establish and maintain procedures to control labeling activities. Labeling shall not be released for storage or use until a designated individual has examined the labeling for accuracy as required by 21 CFR 820.120(b); labeling shall be controlled to prevent mixups; and shall be documented as required by 21 CFR 820.120(d). Labeling procedures have not been established (FDA 483, Item #37). Labeling is not sufficiently examined by a designated individual for accuracy including handling instructions before release (FDA 483, Item #36); and labels and labeling used for each finished product lot, or batch are not sufficiently documented in the DHR and the DHR fails to include records of approval and release of device labeling, including date and signature of reviewer (FDA 483, Item #s 39 & 35).

14. Your firm failed to establish and maintain procedures to ensure there are device history records (DHRs) for each batch or lot to demonstrate that the device is manufactured in accordance with the device master record (DMR) as required by 21 CFR 820.184. DHRs are not maintained for the production of the magnesium oxide and ferric oxide yellow blend (Formula K); your DHRs are not consistent with the DMR master formulas; DHRs fail to show ingredients for each one used; repackaging documentation fails to include or reference acceptance testing procedures and specifications, the container/closures used, labeling used, and sampling requirements; and the DMR for alginate impression material incorrectly lists titanium fluoride as an ingredient, the current lot being used in potassium titanium fluoride (FDA 483, Item #38 (a-e)).

15. Your firm's DMR fail to include or refer to device specifications including appropriate drawings, composition, formulation, and component specifications as required by 21 CFR 820.181(a). Your DMR does not include or refer to the location of device specifications (FDA 483, Item #42).

16. Your firm failed to establish and maintain procedures to control all documents that are required by 21 CFR 820.40. Documentation changes are not reviewed and approved before implementation and no documentation is maintained regarding changes made, e.g., DHR for lot #03240502 includes processing instructions but fails to document changes and how this change impacts the product (FDA 483, Item #43).

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. We acknowledge your written response dated September 29, 2005 to the FDA 483, List of Observations. Your response appears to be inadequate because the response fails to address in sufficient detail any of the specific observations made during the inspection.